FDA 510(k) Applications Submitted by Meghal Khakhar
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K150709 |
03/19/2015 |
ProTrack RF Anchor Wire |
BAYLIS MEDICAL COMPANY INC. |
| K151009 |
04/15/2015 |
Nexus Suture |
BAYLIS MEDICAL COMPANY INC. |
| K101117 |
04/21/2010 |
LEV-OR DILATION CATHETER OTW |
BAYLIS MEDICAL CO., INC. |
| K101372 |
05/17/2010 |
DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20 |
BAYLIS MEDICAL CO., INC. |
| K111523 |
06/01/2011 |
OSTEOCOOL (TM) RF ABLATION SYSTEM |
BAYLIS MEDICAL CO., INC. |
| K101615 |
06/09/2010 |
POWERWIRE RADIOFREQUENCY GUIDEWIRE |
BAYLIS MEDICAL CO., INC. |
| K051670 |
06/22/2005 |
RF TUNNELER WIRE |
BAYLIS MEDICAL CO., INC. |
| K071745 |
06/27/2007 |
BAYLIS PAIN MANAGEMENT SINGLE-USE PROBE |
BAYLIS MEDICAL CO., INC. |
| K161878 |
07/08/2016 |
PORTAGE System |
Baylis Medical Company Inc. |
| K161949 |
07/15/2016 |
OsteoCool V-3 RF Ablation System |
Baylis Medical Company Inc. |
| K152057 |
07/24/2015 |
OsteoCool V-3 RF Ablation System |
BAYLIS MEDICAL COMPANY INC. |
| K122278 |
07/30/2012 |
BAYLIS MEDICAL COMPANY RADIOFREQUENCY PERFORATION GENERATOR |
BAYLIS MEDICAL COMPANY INC. |
| K132374 |
07/30/2013 |
BAYLIS MEDICAL RF PERFORATION PROBE V2.0 |
BAYLIS MEDICAL COMPANY INC. |
| K092337 |
08/04/2009 |
PAIN MANAGEMENT OPTIMA, MODEL PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS |
BAYLIS MEDICAL CO., INC. |
| K102192 |
08/04/2010 |
INDISCAL DIGITAL MANOMETER |
BAYLIS MEDICAL CO., INC. |
| K072478 |
09/04/2007 |
BAYLIS PAIN MANAGEMENT GENERATOR-TD, MODELS: PMG-115-TD AND PMG-230-TD |
BAYLIS MEDICAL CO., INC. |
| K142480 |
09/04/2014 |
OsteoCool V-2 RF Ablation System |
BAYLIS MEDICAL COMPANY INC. |
| K092877 |
09/18/2009 |
INDISCAL ASPIRATION DEVICE AND ACCESSORIES |
BAYLIS MEDICAL CO., INC. |
| K122926 |
09/24/2012 |
SUREFLEX STEERABLE GUIDING SHEATH KIT |
BAYLIS MEDICAL CO., INC. |
| K062937 |
09/28/2006 |
TRANSDISCAL SYSTEM, MODELS TDP-17-150-6, TDI-17-150, TDA-PPU-1, TDA-TBK-1, TDX-Y-TSW-TDP, TDX-PMG-PPU |
BAYLIS MEDICAL CO., INC. |
| K102948 |
10/05/2010 |
TORFLEX TRANSSEPTAL GUIDING SHEATH |
BAYLIS MEDICAL CO., INC. |
| K053082 |
11/02/2005 |
BAYLIS PAIN MANAGEMENT COOLED PROBE, MODEL PMPC-18-150-6 |
BAYLIS MEDICAL CO., INC. |
| K073326 |
11/27/2007 |
NRG TRANSSEPTAL NEEDLE |
BAYLIS MEDICAL CO., INC. |
| K183632 |
12/26/2018 |
Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable |
Baylis Medical Company Inc. |
| K183649 |
12/26/2018 |
Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable |
Baylis Medical Company Inc. |
| K183655 |
12/27/2018 |
VersaCross Transseptal Sheath |
Baylis Medical Company Inc. |
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